On August 18, 2020 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of 53.5 million in the second quarter of 2020 (Q2 2019: NOK 52.1), corresponding to growth of three per cent, despite a significant Covid-19 impact in the beginning of the quarter in the U.S. market before a strong recovery towards the end of the period (Press release, PhotoCure, AUG 18, 2020, View Source [SID1234563726]). The company has entered into an agreement with Ipsen Pharma SAS (Ipsen) for the return of Hexvix sales, marketing and distribution rights from the fourth quarter of 2020 and sees significant growth opportunities in Europe. The agreement is expected to be EBITDA accretive from full-year 2021 and beyond.

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"Our second quarter results were negatively impacted by the Covid-19 pandemic with a significant decline in revenue at the beginning of the quarter but a strong recovery towards the end of the quarter. We are confident that we will return to strong growth rates with continued growth year over year once the Covid-19 epidemic subsides. We believe that BLC with Hexvix/Cysview can play an integral role in assuring that the first TURBT in a patient after postponement of procedures due to Covid-19 will be complete and thorough reducing the risks for repeat TURBT, reoccurrence and progression in that patient," says Daniel Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 53.7 million in the second quarter of 2020 (NOK 53.0 million), with an EBITDA before restructuring of NOK -8.9 million (NOK -2.6 million). The Hexvix/Cysview revenues ended at NOK 53.5 million (NOK 52.1 million). The demand in the U.S. market rebounded at the end of the quarter, with the in-market unit sales for June up 7 per cent compared to June last year.

The installed base of rigid cystoscopes in the U.S. was 246 at the end of the second quarter, an increase of 58 units or 31% since the same quarter last year. Blue Light Cystoscopy (BLCTM) in the surveillance setting is a key priority for Photocure in the U.S. market. By the end of the second quarter, 30 flexible cystoscopes for the surveillance cystoscopy setting have been installed.

Cash balance of NOK 500 million

Photocure had a net cash flow from operations of NOK 11.4 million in the second quarter of 2020 (NOK -4.0 million) and completed two private placements on 27 April and 24 June, raising a total gross of NOK 333 million. The private placements attracted very strong interest from existing shareholders, as well as from new high-quality institutional investors and were multiple times oversubscribed. At the end of the quarter, Photocure had a cash balance of NOK 499.4 million (86.7).

Regains worldwide rights of Hexvix

Photocure has entered into an agreement with Ipsen for the return of Hexvix sales, marketing and distribution rights in Europe and other markets currently controlled by Ipsen. With taking direct control over Photocure’s own Hexvix/Cysview product in key regions, the company supports the ambition of becoming a global leader in bladder cancer with a solid basis for expansion and further growth opportunities. Photocure will commence the Hexvix commercialization in Europe from the fourth quarter of 2020 and expects the Ipsen agreement to be EBITDA accretive from full-year 2021 and beyond.

"In June, we signed the final agreement with Ipsen for the return of the marketing and sales rights for Hexvix in various European countries. This transaction further supports our strategy of building a strong and profitable global business within bladder cancer. We plan to leverage the extensive experience we have built in the U.S. and the Nordics to the markets that were previously controlled by Ipsen. We believe there is tremendous growth and expansion opportunities in all markets previously controlled by Ipsen. In addition, there are many markets where Ipsen never commercialized our products and we plan to address many of these markets in the future. In the second quarter, we successfully raised the necessary capital to fund the required milestone payments, training of people and working capital to transition the European business from Ipsen to Photocure," says Schneider.

Group 2023 ambitions

Photocure delivers transformative solutions that improve the lives of bladder cancer patients. Based on experience and the performance of the breakthrough bladder cancer product Hexvix/Cysview, Photocure has embarked on a stepwise approach for continued growth. Photocure sees significant long-term potential in the global bladder cancer market and has a defined growth strategy:

Accelerating – Drive the breadth and depth of Hexvix/Cysview usage in key accounts
Expanding – Generate sales in new geographies and product enhancements
Acquiring – Products used in the management of bladder cancer patients
Transforming – Partner and in-license assets to strengthen the bladder cancer portfolio
"Based on the outlook and strategic opportunities, Photocure aims to maintain its group revenue ambitions for 2023 in the range of NOK 1 billion with EBITDA margins of approximately 40%, following the completion of the transaction with Ipsen," Schneider concludes.

Please find the full financial report and presentation enclosed.

EBITDA and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the second quarter 2020 financial report on page 22-23.

Photocure will present its second quarter 2020 report on Tuesday 18 August 2020 at 14:00 CET. The investor presentation will be streamed live and be hosted by Daniel Schneider, CEO and Erik Dahl, CFO.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/webcast/hegnarmedia/20200818_11/ . The presentation is scheduled to conclude at 14:45 CET.

On August 18, 2020 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for unmet medical need indications, reported its results for the second quarter and first half of 2020 (Press release, BerGenBio, AUG 18, 2020 View Source [SID1234563725]).

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A presentation and live webcast by BerGenBio’s senior management will take place at 10.00 am CET today, please see below for details.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "Set against the unprecedented backdrop of a global pandemic, this has been an eventful period for BerGenBio. During this time we have continued our focus on progressing clinical trials of our lead candidate bemcentinib in non-small cell lung cancer (NSCLC) and Acute Myeloid Leukaemia (AML) and more recently COVID-19, while ensuring that the safety and wellbeing of our staff and the patients participating in our clinical trials has been and remains our top priority.

"The COVID-19 crisis has and will likely continue to delay clinical trials throughout the sector and as anticipated has impacted patient recruitment into BerGenBio clinical studies and extended previously anticipated timelines. The impact of the pandemic on our clinical trials has continued through the second quarter, but we are pleased that new patients continue to be recruited into our clinical studies with bemcentinib, and already enrolled patients have been able to continue their treatment throughout the restrictions.

"We continue to make progress, with a latest milestone in NSCLC trial presented at the Next Gen Immuno-Oncology Congress conference where 6 of the 7 identified AXL positive patients reported clinical benefit and data showed a 2.5-fold improvement in median Progression-free Survival.

"The Company remains in a strong cash position, with two drug candidates backed by pioneering biology, continued favourable clinical results and important data readouts on the horizon in two major cancer indications, as well as a potential COVID-19 treatment. This is an exciting time for us."

Operational Highlights – second quarter and the first half of 2020 (including post-period end)

Positive interim clinical and translational phase II data with bemcentinib in combination with KEYTRUDA in checkpoint inhibitor refractory NSCLC patients
In June, BerGenBio presented positive data from its Cohort B, stage 1, in the phase II trial evaluating bemcentinib in combination with KEYTRUDA in patients with advanced non-small cell lung cancer (NSCLC) and with confirmed progression on prior immune checkpoint therapy.
The trial included 12 evaluable patients for cAXL, BerGenBio’s proprietary composite-AXL (cAXL) immunohistochemistry biomarker. 7 of these 12 patients were cAXL-positive whereby 6 of these 7 patients reported clinical benefit and 2.5-fold improvement in mPFS.
BerGenBio also reported an update on Overall Survival data from Cohort A, where cAXL-positive patients reported 12-month Overall Survival of 79% and median Overall Survival of 17.3 months, whereas cAXL-negative reported 60% and 12.4 months respectively.
Data was presented at the NextGen Immuno-Oncology Congress, 25 June
First patient dosed in bemcentinib COVID-19 study in June 2020
In April, BerGenBio announced the selection of bemcentinib as the first candidate in a UK Government-backed national ACCORD study.
The study was a multicentre, seamless, Phase II adaptive randomisation platform trial to assess the efficacy and safety of multiple candidate agents for the treatment of COVID-19 in hospitalised UK NHS patients, and the first patient was dosed in June.
At the end of July, the incidence of COVID-19 in the UK had drastically reduced and the UK Research and Innovation’s (UKRI) decided to cease grant funding. Subsequently, the University Hospital Southampton NHS Trust notified all sites in the ACCORD programme to cease the recruitment of new patients into the trial for all candidate agents. Patients already recruited, including those dosed with bemcentinib, will continue on treatment as per the protocol.
The decision to halt the study reflected the significant decrease in the incidence of COVID-19 in the UK and difficulty recruiting a sufficient number of patients and in no way reflected any interpretation of the efficacy or safety of any of the candidate agents.
BerGenBio is now in the late stage set-up phase to sponsor a similar study to ACCORD in a country of high COVID-19 incidence.
First patient dosed in bemcentinib Glioblastoma study in July 2020 (post-period)
In July, BerGenBio announced the first patient was dosed in an investigator-initiated trial (IIT) assessing bemcentinib in recurrent glioblastoma (GBM). The study will enrol up to 20 recurrent GBM patients, at up to 15 sites in the USA.
Increased expression of the receptor tyrosine kinase AXL is significantly correlated with poor prognosis in GBM patients and preclinical data has suggested that bemcentinib may be a promising therapeutic agent for GBM, particularly in post-irradiation mesenchymal-transformed GBM tumors.
A comprehensive translational research programme will run in parallel with the clinical trial.
Q2 2020 Financial Highlights

(Figures in brackets = same period 2019 unless otherwise stated)

Revenue for the second quarter amounted to NOK 0.0 million (NOK 0.0 million) and for the six months ended 30 June NOK 0.0 million (NOK 8.7 million). The revenue in 2019 reflects clinical milestone payments from ADCT.
Total operating expenses for the second quarter amounted to NOK 64.7 million (NOK 52.0 million) and for the six months ended 30 June NOK 121.0 million (NOK 106.5 million). NOK 7.5 million (NOK – 2.5 million) of operating expenses was non cash accruals for option cost.
The operating loss for the quarter came to NOK 64.7 million (NOK 52.0 million) and for the six months ended 30 June NOK 121.0 million (NOK 97.8 million), reflecting the level of activity related to the clinical trials BerGenBio are conducting.
Cash and cash equivalents increased to NOK 828.4 million by 30 June (NOK 419.4 by 31 March 2020).
Private placement completed in May 2020, with gross proceeds NOK 520 million (including NOK 20 million from repair issue in July). Net proceeds to be used to take full advantage of clinical development opportunities stemming from the Company’s technology and to progress readiness for early commercialisation possibilities and general corporate purposes.
Presentation and Webcast Details

A presentation by BerGenBio’s senior management team will take place today at 10:00 am CET:

The second quarter report and presentation is available on the Company’s website in the Investors/Financial Reports section and a recording of the webcast will be made available shortly after the webcast has finished.

On August 17, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported it will host a conference call and webcast to provide a business update on Monday, August 31, 2020 at 4:30 p.m. EDT (Press release, Cue Biopharma, AUG 17, 2020, View Source [SID1234608299]). Live and archived versions of the event can be accessed via the Company’s website.

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Members of the Cue Biopharma executive management team will provide an update on the Company’s ongoing Phase 1 clinical trial of CUE-101 for the treatment of HPV16-driven recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), technology platforms and pipeline progress, as well as updates on its strategic objectives and anticipated milestones.

On August 17, 2020 Astellas reported that The National Institute for Health and Care Excellence has now published final guidance backing NHS use of Xospata as monotherapy for adults with relapsed or refractory FLT3 mutation-positive acute myeloid leukaemia (AML) (Press release, Astellas, AUG 17, 2020, View Source [SID1234563838]).

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The endorsement remains contingent on the confidential commercial agreement agreed with the company, and does not include its use as a maintenance therapy after haematopoietic stem cell transplant.

Each year around 3,100 people in the UK are diagnosed with AML, a rare and aggressive cancer of the blood and bone marrow that, if untreated, can be fatal within a few months.

Around one-third will test positive for the FLT3 gene mutation, which can result in higher relapse rates and lower rates of survival than other forms of the disease.

Data from the Phase III ADMIRAL trial showed that relapsed or refractory FLT3 mutation-positive AML patients who received the drug experienced significantly longer overall survival than those who received salvage chemotherapy.

Median overall survival for patients who received Xospata was 9.3 months, compared to 5.6 months for patients who received salvage chemotherapy, while rates of one-year survival were 37% and 17%, respectively.

On August 17, 2020 JW Therapeutics reported that it has filed the paperwork (PDF) for a Hong Kong IPO (Press release, JW Therapeutics, AUG 17, 2020, View Source [SID1234563831]). The Juno Therapeutics-WuXi AppTech joint venture is seeking money to advance a cell therapy pipeline led by anti-CD19 CAR-T JWCAR029.

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In 2016, Juno and WuXi teamed up to found JW. The biotech went on to raise $190 million over the course of its series A and B rounds, giving it the financial firepower to take JWCAR029 to a filing for approval in third-line diffuse large B-cell lymphoma in China while exploring the effect of the anti-CD19 CAR-T and other cell therapies on a range of different hematological and solid cancers.

Now, with the commercial launch of JWCAR029 in sight, JW has filed to raise money in a Hong Kong IPO. The financing target is redacted from the paperwork, but earlier media reports suggest JW plans to raise $200 million to $300 million.

JW is seeking the money to continue developing JWCAR029, which is in development in five blood cancers, and build out an in-house sales and marketing team to support the launch of the CAR-T in China. The rest of the money will support development of JWCAR129, an anti-BCMA therapy that is in IND-enabling studies, and a solid tumor pipeline led by anti-AFP cell therapy JWATM203.

JWATM203 is yet to enter the clinic, but JW’s partner, Eureka Therapeutics, has taken its AFP T-cell therapy into phase 1/2 in the U.S. JW and Eureka are developing the AFP cell therapies as treatments for liver cancer.

JW has another anti-AFP asset, JWATM213, in development that uses technology accessed through a collaboration with Lyell to enhance T-cell function and improve efficacy. Lyell and JW disclosed their solid tumor collaboration, which also includes an anti-GPC3 program, last week. The IPO paperwork fleshes out the details, revealing Lyell has granted JW a license to T-cell anti-exhaustion functionality.

The partnership brings together biotechs with strong links to Juno. Lyell’s founder and CEO is Rick Klausner, the co-founder of Juno. JW was set up by pioneering Seattle-based CAR-T biotech Juno.